Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06625398
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
An Efficacy Safety and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease TED
Sponsor:
None
Organization:
None
Study Overview
Official Title:
REVEAL-2 - a Phase 3 Randomized Double-masked Placebo-controlled Efficacy Safety and Tolerability Study of VRDN-003 in Participants with Chronic Thyroid Eye Disease TED
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVEAL-2
Brief Summary:
This is a clinical trial assessing the efficacy safety and tolerability of an investigational drug VRDN-003 in participants with chronic Thyroid Eye Disease TED
Detailed Description:
This is a randomized meaning participants will be assigned to study arms by chance double-masked meaning study doctor and participant will not know which study arm participant is assigned to placebo-controlled study that will include participants with chronic TED The key objectives of this study are to determine if VRDN-003 is efficacious safe and tolerable when administered as subcutaneousSC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED
Participants who do not have a meaningful response at Week 24 may be eligible to receive additional subcutaneous injections of VRDN-003
Participants who do not have a meaningful response at Week 24 may be eligible to receive additional subcutaneous injections of VRDN-003
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None